進行性または転移性胆道癌に対するバルリチニブとカペシタビンの併用療法

基本情報

NCT ID: NCT03093870
ステータス: 完了
試験のフェーズ: 第2/第3相
試験タイプ: 介入
目標被験者数: 151
治験依頼者名: ASLAN Pharmaceuticals

概要

This protocol for Varlitinib is developed for the treatment of Biliary Tract Cancer. Varlitinib (also known as ASLAN001) is a small-molecule, adenosine triphosphate competitive inhibitor of the tyrosine kinases - epidermal growth factor receptor (EGFR), human epidermal growth factor receptor (HER)2, and HER4. Varlitinib may be beneficial to subjects with cancer by simultaneous inhibition of these receptors. The purpose of this study is to determine the safety and efficacy of Varlitinib in combination with capecitabine for the treatment of Biliary Tract Cancer. Treatment groups are Varlitinib+capecitabine and Placebo + capecitabine

対象疾患

Biliary Tract Cancer

介入

Varlitinib(DRUG)

Capecitabine(DRUG)

Placebo (for Varlitinib)(DRUG)

依頼者（Sponsor）

Biorasi(INDUSTRY)

Cmic Co, Ltd. Japan(INDUSTRY)

Aslan(OTHER)

Syneos Health(OTHER)

実施施設 (1)

There are 7 sites in different cities in Japan

Chiba, Japan